| Primary Device ID | 10628678061023 |
| NIH Device Record Key | 5f79c941-8bc9-4df2-8653-6daf0554d605 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Syringe, 10 mL |
| Version Model Number | E01P3 |
| Catalog Number | E01P3 |
| Company DUNS | 242512799 |
| Company Name | Front Line Medical Technologies Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10628678061023 [Primary] |
| GS1 | 16286780610023 [Previous] |
| MJN | Catheter, Intravascular Occluding, Temporary |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 16286780610023 | The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ |
| 10628678061023 | The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ |
| 10628678061061 | The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ |